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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03358758
Other study ID # 06032017
Secondary ID
Status Completed
Phase N/A
First received November 27, 2017
Last updated November 27, 2017
Start date October 16, 2016
Est. completion date July 10, 2017

Study information

Verified date November 2017
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A retrospective morbidity and mortality study, using routinely collected data, investigating the epidemiology of patients with conflict-related injuries presenting to a dedicated trauma hospital in Erbil, Iraq, during the campaign to liberate Mosul from ISIS.


Description:

Trauma is a major cause of morbidity and mortality worldwide. An analysis of the Global Burden of Disease study indicated that in 2013, globally 973 million traumatic injuries warranted medical intervention, while 4.8 million injuries were fatal. The Small Arms Survey - Global Burden of Armed Violence report compiles worldwide conflict-related data and indicates that between 2007-2012, there were a total of 508,000 fatalities attributable to interpersonal violence worldwide, of which 70,000 were conflict-related. Since the U.S. invasion of Iraq in 2003, the country has perpetually constituted a scene of conflict. Hagopian et al reports that in the period 2003-2011, there were between 48,000 and 751,000 excess deaths attributable to the conflict.

In 2014, a new group, Islamic State of Iraq and Syria (ISIS), made significant territorial gains in several governorates in Iraq and captured key cities, including Fallujah and Mosul. ISIS is unique among terrorist groups in that it employs a combination of conventional maneuver warfare tactics with terrorist tactics such as Improvised Explosive Devices (IEDs) and Vehicle-Born Improvised Explosive Devices (VBIEDs) in order to capture and hold territory. These indiscriminate tactics lead to excessive civilian casualties.

In mid-October 2016 the offensive to liberate Mosul started. Emergency Hospital (EH) is one hospital assigned by the Kurdistan Ministry of Health to receive trauma patients from the conflict, and is located in Erbil, around 94 Km east of Mosul. EH is a dedicated trauma hospital that was set up in 1997. Since mid-October 2016 EH is exclusively providing care to injured from the armed conflict. Initially EH and WEH were the only hospitals providing surgical trauma care to patients from Mosul but since late December 2016 secondary facilities have opened closer to Mosul. The two hospitals are since then mainly referral hospitals.

Previous research on trauma from conflict zones generally focus solely on military combatants. Due to the use of ballistic protection and forward surgical teams these results may not be applicable to a civilian setting. A few organizations, such as the Médecins Sans Frontières (MSF), have reported on civilian casualties in conflict zones; however, these have been reports from single centers and articles are sometimes published several years after the trauma occurred. More timely information is needed on the type and pattern of injury for both combatants and civilians. ISIS tactics are likely to have a significant impact on the type of injuries seen at EH. An increased understanding of this impact is essential for addressing emerging resource requirements. The investigators anticipate a high incidence of blast- and firearm-related injuries in both civilians and combatants. This study utilizes existing data from the hospital to gain knowledge of the characteristics of conflict-related injuries, as well as the demographic profile of the patients. Furthermore, the data will be used to investigate how morbidity and mortality varies depending on injury type.

Specific aims:

1. Describe the demographics of patients with conflict-related injuries presenting to the EMC during the Mosul campaign.

2. Describe the morbidity profile of the study population, specifically:

1. Determine how markers for injury severity vary with injury mechanism and patient status as combatant or non-combatant.

2. Compare how injury mechanism varies with patient identity as non-combatant, ISF or Peshmerga.

3. Determine the in-hospital mortality rate.

This is essential both for generating actionable results necessary to direct operational priorities, and gaining an understanding of the wider public health impact of the ongoing conflict. The evidence generated by this study will facilitate effective programmatic monitoring and help optimize resource allocation to meet the rapidly changing health needs in the area.


Recruitment information / eligibility

Status Completed
Enrollment 1832
Est. completion date July 10, 2017
Est. primary completion date July 10, 2017
Accepts healthy volunteers
Gender All
Age group N/A to 99 Years
Eligibility Inclusion criteria: All patients from Mosul presenting with conflict-related injuries to Emergency Hospital between October 16, 2016 to July 10, 2017.

Exclusion Criteria:

- Non-conflict related injures, Patients not categorised as either civilian or combatant

Study Design


Locations

Country Name City State
Sweden Karolinska Institute Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Morbidity Site of injury, mechanism of injury, patient status as combatant or non-combatant October 16, 2016 to July 10, 2017
Primary Mortality In-hospital mortality October 16, 2016 to July 10, 2017
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